X-Pac Expandable Lumbar Cage System

Intervertebral Fusion Device With Bone Graft, Lumbar

Expanding Innovations, Inc.

The following data is part of a premarket notification filed by Expanding Innovations, Inc. with the FDA for X-pac Expandable Lumbar Cage System.

Pre-market Notification Details

Device IDK201145
510k NumberK201145
Device Name:X-Pac Expandable Lumbar Cage System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Expanding Innovations, Inc. 110 Pioneer Way, Suite I Mountain View,  CA  94041
ContactMbithi Muthini
CorrespondentNancy Lince
Lince Consulting, LLC 111 Deerwood Road, Suite 200 San Ramon,  CA  95483
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-29
Decision Date2020-09-10

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